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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00383188




Registration number
NCT00383188
Ethics application status
Date submitted
28/09/2006
Date registered
2/10/2006
Date last updated
12/10/2009

Titles & IDs
Public title
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Scientific title
A 12-Week, Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis
Secondary ID [1] 0 0
A6631007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804

Placebo Comparator: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -

Experimental: 5 -


Treatment: Drugs: placebo
Capsule, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Is PH-797804, a p38 inhibitor, safe and tolerated as a monotherapy agent for 12 weeks in subjects with RA and who have failed at least 1 DMARD
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Is PH-797804, a p38 inhibitor, efficacious in the selected dose range with additional characterization by PK in a 12-week treatment period in subjects with RA and who have failed at least 1 DMARD
Timepoint [1] 0 0
16 weeks

Eligibility
Key inclusion criteria
- Diagnosed with RA and has failed at least 1 DMARD therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any other inflammatory arthritis and any significant history of acute or chronic
infection with immunomodulatory etiology

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Malvern East
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Paraná
Country [2] 0 0
Brazil
State/province [2] 0 0
PR
Country [3] 0 0
Brazil
State/province [3] 0 0
SP
Country [4] 0 0
Chile
State/province [4] 0 0
RM
Country [5] 0 0
Chile
State/province [5] 0 0
V Region
Country [6] 0 0
Chile
State/province [6] 0 0
VI Región
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Brno
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Olomouc
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Ostrava - Trebovice
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 4
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Zlin
Country [13] 0 0
Estonia
State/province [13] 0 0
Tallinn
Country [14] 0 0
India
State/province [14] 0 0
Andhra Pradesh
Country [15] 0 0
India
State/province [15] 0 0
Karnataka
Country [16] 0 0
India
State/province [16] 0 0
Maharashtra
Country [17] 0 0
India
State/province [17] 0 0
Punjab
Country [18] 0 0
India
State/province [18] 0 0
Tamil Nadu
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Anyang
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Peru
State/province [21] 0 0
Lima
Country [22] 0 0
Poland
State/province [22] 0 0
Bialystok
Country [23] 0 0
Poland
State/province [23] 0 0
Poznan
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Smolensk
Country [27] 0 0
Russian Federation
State/province [27] 0 0
St. Petersburg
Country [28] 0 0
South Africa
State/province [28] 0 0
Gauteng
Country [29] 0 0
South Africa
State/province [29] 0 0
Johannesburg
Country [30] 0 0
South Africa
State/province [30] 0 0
Bloemfontein
Country [31] 0 0
South Africa
State/province [31] 0 0
Durban
Country [32] 0 0
South Africa
State/province [32] 0 0
Kempton Park
Country [33] 0 0
South Africa
State/province [33] 0 0
Pretoria
Country [34] 0 0
Spain
State/province [34] 0 0
Vizcaya
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who
have failed at least 1 DMARD.
Trial website
https://clinicaltrials.gov/show/NCT00383188
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications